FDA cancels requirement for use of VA Electronic Medical Record (EMR) System

FDA has issued notice of cancellation for VA EMR system as part of Solicitation #  FDA_SOL_1194299 to fulfill the requirements listed below

“The FDA/NCTR/Division of Bioinformatics and Biostatistics (DBB) requires use of the large electronic medical record (EMR) system to conduct research to assess the safety and surveillance of FDA regulated products through the FDA adverse event reporting systems, with the pilot study working on the FDA Adverse Events Reporting System (FAERS) (CDER) database. A novel data mining and data visualization method will be developed and evaluated by using a large electronic medical record (EMR) system, such as VA databases, for drug induced cardiovascular abnormalities (i.e high blood pressure, stroke, QT prolongation, and arrhythmia) after drug exposure…”

“… The VA Cardio-related database (using drug-induced cardiovascular disease as a starting point) will be developed and used for this contract. The database will be developed using the VA Informatics and Computing Infrastructure (VINCI) database of the VA National EMR system, including drugs, adverse events, lab data, ECG, dose and drug co-exposure information, etc. The database requires drug dictionary, laboratory dictionary, ICD-9 dictionary, patients receiving any of the study drugs, patients with cardio events, exclude other cases of acute cardiovascular disease, medication-matched control population database, study population table and cardio event tables, patient demographic table, comedications taken at time-of cardio events, database of comorbidities at cardio events and model implementation. Due to the strict restriction on the permission to access the VA database and specific skill to retrieve and process the data, contractors shall have authority to access the VA database. The FDA has no access or provide access to the VA National EMR system…”

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